Infant,Premature
Conditions
Keywords
apnea of prematurity, bradycardia, hypoxemic episode, oxygen delivery
Brief summary
To determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes
Detailed description
This study will enroll the subset of infants enrolled in the main study (PreVENT Aim 1; 401-1000g at birth and/or 22w 0d-28w 6d; enrolled at \<1 week postnatal age; eligible for full care and surviving beyond 24 hours, with informed consent; and with no major malformations) who are receiving oxygen supplementation at 32w and 36w postmenstrual age (PMA), and are not judged too unstable by the Attending neonatologist. For infants on oxygen supplementation at 32w PMA, the investigators will use data from the 96 hours of intensive multiparametric physiologic monitoring at 32w PMA. For infants on oxygen supplementation at 36w PMA, we will use the 96 hours of intensive multiparametric physiologic monitoring at 36w PMA as well as data from the sleep study. The first 24 hours of data collection will be the baseline data. Over the next 72 hours, the investigators will evaluate 3 interventions in a cross-over manner with the initial intervention (cannula or oxygen environment) randomly assigned: Intervention 1 (24-48h of data), Intervention 2 (48-72h of data) and Intervention 3 (72-96h of data).
Interventions
DIAGNOSTIC_TESTCardiorespiratory monitoring
The investigators will use high resolution physiologic monitoring of Heart Rate, Respiratory Rate, Pulse oximetry, (and near-infrared monitoring as well as microcapnography in selected infants) to evaluate control of breathing (apnea, bradycardia, desaturations)
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
(b) The first 24h of the data collection will be the baseline data. Over the next 72h, we will evaluate 3 interventions in a cross-over manner: Intervention 1 (24-48h of data), Intervention 2 (48-72h), and Intervention 3 (72-96h; same as intervention 1). Initial intervention will be by random assignment (computer-generated). The intervention will be to provide oxygen either by nasal cannula or by servo-controlled oxygen environment, followed by cross-over to other intervention for 24h, and then back to original intervention.
Eligibility
Sex/Gender
ALL
Age
1 Days to 98 Days
Healthy volunteers
No
Inclusion criteria
\- Inborn infants weighing 401-1,000 grams on admission and/or 22w 0/7d to 28w 6/7d (\<29 weeks) inclusive completed weeks of gestation Infants eligible for full care and resuscitation as necessary, and surviving beyond 24 h of age Enrollment in main study protocol (Aim 1 of PreVENT Apnea) at \<1 week post-natal age This study will enroll the subset of infants from Aim 1 who are receiving oxygen supplementation at 32w and 36w PMA, and are not judged too unstable by the Attending neonatologist Informed consent from parent/guardian
Exclusion criteria
\- Refusal or withdrawal of consent Major congenital malformations (e.g., not including patent ductus arteriosus, small hernia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxemic episode | During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment) | Hypoxemic episode defined as as oxygen saturation by pulse oximetry (SpO2) \<85% for \>10 seconds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bradycardic episode | During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment) | Bradycardic episode defined as heart rate (HR) \<100/min for \>10 seconds |
| Apnea episodes | During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment) | Apnea defined as Respiratory Rate (RR)=0 for \>20 seconds, or RR=0 for \>10 seconds + oxygen saturation by pulse oximetry (SpO2) \<85% or heart rate (HR) \<100/min |
| Hypoxemic time defined as duration of time with SpO2 <85% | During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment) | Hypoxemic time defined as duration of time with SpO2 \<85% |
Countries
United States
Outcome results
None listed